MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2029-03-31

Brief Summary

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Cardiac allograft vasculopathy (CAV) is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. Surveillance for CAV is vital; however an ideal approach has not been established. The goal of this study is to assess whether noninvasive positron emission tomography (PET) based surveillance is non-inferior to invasive coronary angiography (ICA) surveillance.

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Detailed Description

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MARINER is a Canadian multicentre prospective, randomized clinical outcomes-based trial evaluating noninferiority of a noninvasive PET strategy compared to ICA for CAV surveillance. Patients are randomized to annual PET or ICA for CAV surveillance. Non-inferiority is assessed according to a clinical composite of death, retransplant, allograft dysfunction not related to acute rejection, and angiographic CAV associated with myocardial infarction or heart failure. Secondary outcomes include the rate of new or progressive CAV, number of ICA performed, number of ICA and PET procedural related complications, EuroQol-5 Dimension assessed patient health-related quality of life and health care resource use.

Conditions

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Cardiac Allograft Vasculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization to PET or ICA

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Invasive Coronary Angiography

Patients in this arm will undergo annual CAV surveillance with ICA

Group Type OTHER

ICA

Intervention Type DIAGNOSTIC_TEST

Patients will undergo annual CAV surveillance with ICA

Positron Emission Tomography

Patients in this arm will undergo annual CAV surveillance with PET

Group Type OTHER

PET

Intervention Type DIAGNOSTIC_TEST

Patients will undergo annual CAV surveillance with PET

Interventions

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ICA

Patients will undergo annual CAV surveillance with ICA

Intervention Type DIAGNOSTIC_TEST

PET

Patients will undergo annual CAV surveillance with PET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Post heart transplant 2-10 years.
2. Age ≥18 years.
3. Able to provide informed consent.

Exclusion Criteria

1. Contraindication to dipyridamole due to severe aortic stenosis.
2. Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker.
3. Contraindication to dipyridamole due to severe bronchospasm.
4. Unable to undergo coronary angiography due to allergy to iodinated contrast.
5. Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2. for non-dialysis patients as determined by local laboratory analysis.
6. Unable to undergo coronary angiography due to unsuitable vascular access.
7. Treated rejection ≤1-month.
8. Unstable angina or MI ≤7 days.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No